海正藥業(600267.SH):鹽酸伊立替康注射液註冊申請主動撤回並獲得批准
格隆匯 6 月 29日丨海正藥業(600267.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)關於公司主動申請撤回鹽酸伊立替康注射液藥品註冊申請的《審批意見通知件》。
公司於2012年05月09日按原化學藥品註冊分類6類向浙江省藥品監督管理局提交鹽酸伊立替康注射液藥品註冊申請並獲得受理。基於目前生產條件和市場競爭情況的評估,結合公司實際,經認真研究後決定向國家藥監局主動撤回該藥品註冊申請。近日,公司收到國家藥監局核准簽發的鹽酸伊立替康注射液《審批意見通知件》,同意本品註冊申請撤回,終止註冊程序。
鹽酸伊立替康注射液適用於晚期大腸癌患者的治療。原研藥由Pfizer公司研發,國內生產廠商主要有海南錦瑞製藥有限公司、江蘇恆瑞醫藥股份有限公司等。經查詢IMS數據庫,鹽酸伊立替康注射液2019年全球銷售額為64645.20萬美元,其中中國銷售額為13879.39萬美元;2020年1-3月全球銷售額為15867.81萬美元,其中中國銷售額為3004.95萬美元。截至目前,公司在該產品研發項目上已投入301.17萬元人民幣左右。
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